The present invention relates to tissue sampling devices known as biopsy needles, and in particular, to clips for use in manipulating and transporting such biopsy needles.
A typical biopsy needle for use in obtaining tissue samples is composed of two parts, a first inner needle and a second outer needle. The first inner needle consists of a solid shaft, having a first handle disposed at one end. A cutting point, to facilitate insertion of the needle into the tissue to be sampled, is located at the opposite end of the shaft from the first handle. Positioned just away from the cutting point, toward the first handle, is the tissue holding region, which is in the form of a cut out region in the shaft.
The second outer needle is made up of a hollow shaft, also at one end of which is disposed a second handle. A passageway extends through the second handle, connected to the hollow shaft, to enable the solid shaft of the first inner needle to be inserted into the passageway and into and through the hollow shaft of the second outer needle.
The first inner needle is greater in length than the entire second outer needle structure. When the first and second handles are placed in a particular spaced position, the hollow shaft of the second outer needle covers the tissue holding region. The tissue holding region may be exposed by inserting the first inner needle further into the second outer needle, bringing the first and second handles closer together. To obtain a tissue sample, the biopsy needle is inserted into a patient, into the tissue to be sampled, with the first inner and second outer needles relatively positioned so that the tissue holding region is covered. The tissue holding region then is exposed, by the operator holding the second handle of the second outer needle motionless while thrusting the first inner needle forward. A portion of the tissue moves into the tissue holding region.
The second outer needle, which also has a cutting point disposed at the end of the hollow shaft opposite the second handle, is then thrust forward, relative to the now-held motionless first inner needle, to cut off the tissue sample from the rest of the tissue, and cover the tissue sample. The angled cutting point of the second outer needle serves to sever the tissue sample. Accordingly, the first inner and second outer needles must be placed in a particular rotational orientation, with respect to one another, prior to insertion, so as to preclude unnecessary manipulation of the needles while in the patient. Specifically, the leading tip of the angled point of the second outer needle must be positioned so as to pass over the tissue holding region. It is therefore desirable to provide a means for retaining the needles in such particular rotational orientation, prior to insertion, and as well during removal.
When the tissue cutting step is accomplished, then the first inner and second outer needles have been brought back to the same relative positions which they occupied prior to initial insertion of the biopsy needle into the patient. To prevent loss or contamination of the tissue sample, the first inner and second outer needles must be removed in this configuration from the patient as well. It is desirable, therefore, to provide a means for maintaining the needles in the appropriate relative positions during removal.
As the configuration of the first inner and second outer needles, which is appropriate for initial insertion, and final removal from the patient, requires that the first and second handles be held spaced apart, the manipulation of such a biopsy needle requires considerable dexterity and concentration on the part of the operator. The concentration necessary to maintain the proper spacing may detract from the concentration necessary to make insertion and removal of the biopsy needle as painless as possible for the patient.
In an alternative usage of a biopsy needle, such a needle is deployed with an automatic device which accomplishes the intermediate steps between initial insertion and final removal. Such an automatic tissue sampling machine is disclosed in U.S. Pat. No. 4,699,154 issued to Lindgren. Prior to loading the biopsy needle into the tissue sampling machine, in the required configuration, the first inner and second outer needles must still be maintained in such position, to facilitate mounting of the biopsy needle in the tissue sampling machine. Further, once removed from the tissue sampling machine, the first inner and second outer needles must still be maintained in the original configuration, to keep the tissue holding region covered and prevent loss or contamination of the tissue sample.
It is desirable therefore to provide a means for maintaining the first inner and second outer needles of a biopsy needle in a predetermined spaced configuration during initial manual insertion and removal.
Still another object of the invention is to provide a means for preventing rotation of the first inner and second outer needles with respect to one another, once the needles have been positioned in a predetermined desired relative orientation.
It is a further object of the invention to provide a means for maintaining the first inner and second outer needles of a biopsy needle in the desired configuration for preventing loss or contamination of the obtained tissue sample during transportation of the biopsy needle for deposit of the tissue sample.
Yet another object of the invention is to provide a means for maintaining the first inner and second outer needles of a biopsy needle in the appropriate configuration for loading into a tissue sampling machine, and upon removal after use thereof.
These and other objects of the invention will become apparent in light of the present Specification, Drawings and claims.